Optimizing Abiraterone Therapy
Completed
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Registration Number
- NCT02426333
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
The purpose of this study is to explore whether early abiraterone exposure is related to treatment response in patients with metastatic castration resistant prostate cancer. Furthermore to explore the relation between biomarkers and treatment response and drug exposure.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
- Patients with metastatic castration resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated
- Age ≥18 years
- Feasible to collect blood samples from
- Life expectancy of > 6 months
- Measurable disease
- Able and willing to give written informed consent prior to screening and enrollment
Exclusion Criteria
- other anticancer therapies
- potent CYP3A4 inducers
- herbal medicine that could interfere with abiraterone exposure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method abiraterone AUC 6 months
- Secondary Outcome Measures
Name Time Method biomarkers: relation between biomarkers and treatment response 6 months relation between biomarkers and treatment response
biomarker reduction 6 months To explore the if reduction in biomarkers is related to treatment response after three and six months
Trial Locations
- Locations (3)
Jeroen Bosch Ziekenhuis
🇳🇱Den Bosch, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Radboud UMC
🇳🇱Nijmegen, Netherlands
Jeroen Bosch Ziekenhuis🇳🇱Den Bosch, Netherlands